Medication Monitor

Generic Name (Trade Name—Company)
April 25, 2019

Generic naloxone

(Narcan generic—Teva)
FDA approves first generic naloxone nasal spray to treat opioid overdose

FDA has granted final approval of the first generic naloxone hydrochloride nasal spray, commonly known as Narcan, a life-saving medication that can stop or reverse the effects of an opioid overdose. The agency is also planning new steps to prioritize the review of additional generic drug applications for products intended to treat opioid overdose, along with the previously announced action to help facilitate an OTC naloxone product.

Though the approval is the first generic naloxone nasal spray for use in a community setting by individuals without medical training, generic injectable naloxone products have been available for years for use in a health care setting. FDA also has previously approved a brand-name naloxone nasal spray and an auto-injector for use by those without medical training.

In a press announcement, FDA said that while business and other considerations may affect how quickly this product becomes available, the approval is an important step for the agency as it works toward expanding access to this live-saving drug. FDA also held a two-day advisory committee meeting in December to solicit input and advice on strategies to increase the availability of naloxone products intended for use in the community.

Naloxone nasal spray does not require assembly and delivers a consistent, measured dose when used as directed. This product can be used for adults or children and is easily administered by anyone, even those without medical training. The drug is sprayed into one nostril while the patient is lying on his or her back and can be repeated if necessary.

Use of naloxone nasal spray in patients who are opioid-dependent may result in severe opioid withdrawal characterized by body aches, diarrhea, increased heart rate, fever, runny nose, sneezing, goose bumps, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness, and increased blood pressure.